Study of Cimzia for the Treatment of Ulcerative Colitis (UC CIMZIA)

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The purpose of this study is to determine if Cimzia (certolizumab pegol) is an effective treatment for patients with Ulcerative colitis.

Condition or disease

Intervention/treatment

Phase

Ulcerative Colitis

Drug: Cimzia

Phase 2

Detailed Description:

Ulcerative colitis (UC) is a chronic inflammatory bowel disease which often results in significant morbidity as well as impairment in quality of life. Cimzia (certolizumab pegol), an inhibitor of tumor necrosis factor-alpha, is an effective treatment for Crohn's disease, a similar inflammatory bowel disease. The aims of this study are to determine if Cimzia is effective for both the induction and maintenance of response/remission for the patients with moderate to severe Ulcerative colitis.

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Ability to understand the study protocol and treatments, willingness to comply with all study requirements, and ability to provide informed consent

No history of prior tuberculosis (TB), no signs or symptoms of active TB, and negative Quantiferon gold test or PPD and chest X-ray showing no active or latent TB at screening or within the 6 months prior to the screening visit.

Rectally administered topical 5-aminosalicylates (5-ASAs)/corticosteroids: must be discontinued by 1 month prior to baseline; not allowed during the study

Oral 5-ASAs: allowed if at stable dose for at least 2 weeks prior to baseline; can remain on this stable dose during the study

Antibiotics for UC: must be discontinued by 1 month prior to baseline; not allowed during the study

Antidiarrheals: must be discontinued by 2 weeks prior to baseline; not allowed during the study

Corticosteroids: allowed if at Prednisone dose equivalent of 20 mg/d or less, stable for 2 weeks prior to baseline (dose/taper during study discussed below); budesonide is allowed at a dose less than or equal to 9 mg/day if at stable dose for 2 weeks prior to baseline

6-Mercaptopurine (6MP)/Azathioprine/Methotrexate: allowed if on for at least 8 weeks, at stable dose for at least 4 weeks prior to baseline; can remain on this stable dose during the study

Anti-TNF therapy: Patients must be naive to CZP. Patients may have had prior exposure to anti-TNF therapy (e.g., infliximab, adalimumab, golimumab), however patients who are primary non-responders to more than one anti-TNF medication are excluded. Patients must have been off their prior anti-TNF medication for at least 8 weeks prior to baseline.

Integrin inhibitor therapy: Patients may have had prior exposure to integrin inhibitor therapy (e.g., vedolizumab). Patients must have been off of integrin inhibitor therapy for at least 8 weeks prior to baseline.

Cyclosporine: patients previously receiving Cyclosporine for UC must have been off their prior Cyclosporine therapy for at least 4 weeks prior to baseline.

Any other medications for the treatment of Ulcerative colitis or investigational medications: must be discontinued at least 1 month or 5 half-lives (whichever is longer) before baseline; not allowed during the study

Female subjects of childbearing potential must agree to practice an effective method of birth control during the study and for 12 weeks after the last dose of study drug. Acceptable methods include: oral contraceptives, transdermal contraceptives, injectable contraceptives, implants, intrauterine devices, barrier methods with spermicide, or surgical sterility.

Colonic dysplasia (except sporadic adenomas). Also, patients found to have colonic dysplasia at any time during the study will be withdrawn from the study.

HIV, chronic or active hepatitis B or C, or patients considered at high risk for these infections (obtained by history/detailed medical chart review except for hepatitis B, which will be tested for with blood sample)

Prior opportunistic infection within 6 months of screening or prior opportunistic infection while on other anti-TNF therapy